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Home > Protocol Summaries: Compounds > GW876008 > Protocol Summary for CRI103143

Protocol Summary for CRI103143

Protocol Summary
Protocol Id: CRI103143
Secondary Ids:
Title: A Phase IIa, single-centre, randomised, placebo-controlled, double-blind, three-period crossover study investigating the effects on gut autonomic responses of single administrations of either 20 mg or 200 mg GW876008, a CRF1 antagonist, to adult patients with irritable bowel syndrome
Phase: Phase 2
Acronym:
FDA Regulated Intervention?:
Section 801 Clinical Trial?:
Delayed Posting:
IND/IDE Protocol?: no
Study Type: interventional
Oversight Authority:
  • United Kingdom: Medicines and Healthcare Products Regulatory Agency
Collaborators:
Brief Summary: The purpose of this study is to see if GW876008 in Irritable Bowel Syndrome patients will reverse stress-induced hypersensitivity, by looking at thresholds for perception and pain.
Detailed Description:
Record Verification Date: September 2009
Status: Completed
Why Study Stopped:
Study Start Date: December 2006
Study Completion Date: October 2007
Study Completion Date Type: Actual
Primary Completion Date:
Primary Completion Date Type: None
Primary Purpose: Treatment
Allocation: Randomized
Masking: Double Blind
Masked Subject: false
Masked Caregiver: false
Masked Investigator: false
Masked Assessor: false
Study Design (Assignment): Crossover Assignment
Study Classification (Endpoint): Pharmacodynamics Study
Primary Outcomes:
  • Change in regional rectal mucosal blood flow in response to a cold water pressor test and in response to a listening test.
Secondary Outcomes:
  • Thresholds for rectal pain sensitivity
Conditions:
  • Irritable Colon
Keywords:
  • IBS
  • CRF1
  • stress
Eligibility Criteria: Click to view inclusion/exclusion criteria
Gender: Both
Minimum Age: 18 Years
Maximum Age: 65 Years
Enrollment: 10
Enrollment Type: Actual
Healthy Volunteers?: no
Central Contact: US GSK Clinical Trials Call Center
Central Contact Phone: 877-379-3718
Central Contact Email: GSKClinicalSupportHD@gsk.com
Backup Central Contact: EU GSK Clinical Trials Call Center
Backup Central Contact Phone: +44 (0) 20 8990 4466
Backup Central Contact Email: GSKClinicalSupportHD@gsk.com
Overall Study Official: GSK Clinical Trials
Overall Study Official Affiliation: GlaxoSmithKline
Overall Study Official Role: Study Director
Responsible Party Name/Official Title: Cheri Hudson; Clinical Disclosure Advisor
Responsible Party Organization: GSK Clinical Disclosure
Location and Contact Information: Click to view location information